Korea's Ministry of Food and Drug Safety (MFDS) - Global Regulatory Partners, Inc. Medical Devices in South Korea are regulated by the Ministry of Food and drug safety (MFDS) formerly known are the Korean Food and Drug Administration (KFDA). Registering medical devices and IVD in S. Korea is a complex and challenging process. Most of MFDS regulations are not written clearly and some are only available in the Korean language. Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in S. Korea. Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in the South Korea’s market. An ICC in S. Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval.An ICC ensures that labeling is accurately added to the product (in Korean), documenting and reporting adverse events or product failures, etc.An ICC can also act as a liaison between the foreign manufacturer and its S. Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests. Contact us to learn more about our Local Agent services in S.Korea. Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in  South Korea so they can  successfully register and commercialize their products in South Korea’s market and maximize the value of their assets.regulatory intelligence,regulatory strategy,regulatory operations, and publishing;product registration,registration amendments;consulting meetings with regulatory authorities. Registering medical devices and IVD in South Korea is a complex and challenging process. Most of MFDS regulations are not that clear, are in Korean language and are changing constantly. Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in South Korea.Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign medical device companies to register their products quickly and efficiently.Identify and the latest regulatory requirements related to your medical device or IVD.Proactively identify challenges or issues that may delay the approval of your medical device in South Korea.Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.Propose innovative solutions and approaches to circumvent these challenges ahead of time.Identify the most cost-effective way to get your medical product registered in South Korea. Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner. At Global Regulatory Partners Inc., (GRP) a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in South Korea. Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in South Korea. As the MFDS Regulatory authorities expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules. Contact us to learn more about our Regulatory Strategy services in South Korea. The first step in the registration process is the determination of the classification of your device according to the rules found in MFDS Notification No. 2014-110. In South Korea (S. Korea), medical devices are classified as Class I, Class II, Class III or Class IV based on increasing risk. A database including medical device descriptions, classifications and categories can be found on the MFDS website. The registration of medical device in S. Korea will vary depending on device classification and the existence of a predicate device registered in S. Korea.  In South Korea, some medical devices may be classified as “quasi-drug” or “drug” even though the same products are classified as medical devices in the US or EU. There are 2 regulatory pathwaysWith a registered predicate (Substantial Equivalent), product registration applications qualify for third party review of the medical device and quality systems conformity assessments.All other Class II devices are subject to a Safety and Efficacy Review by the MFDS with an 80-day processing time. We can determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration.Appointing us as your Korean Registration Holder, ICC, will allow you to maintain more control over your registrations and to add or remove distributors at any time.Our experienced consultants can update your existing FDA or ISO 13485 compliant quality system to meet Korea’s Good Manufacturing Practice (GMP) requirements.We can assist you with KFDA Lab certification coordination, if necessary. Contact us to learn more about our Medical/IVD Registration services in South Korea. As of 2015, companies must undergo KGMP auditing at the beginning of product registration, rather than after the product is approved by the MFDS. Furthermore, in vitro diagnostic (IVD) products are now regulated as medical devices instead of pharmaceuticals. IVD manufacturers must therefore comply with KGMP requirements as well. One major step for companies registering medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III, and IV medical devices. MFDS will verify KGMP compliance via onsite inspections, conducted either by its own staff or with the assistance of Third-Party Auditor.Following submission of KGMP certification application, companies’ manufacturing site will likely undergo inspection by a qualified third-party auditor and/or MFDS depending on devices’ classification:For Class II medical devices, manufacturing sites are subject to third-party audits only.For Class III and IV devices, manufacturing sites are subject to a combined audit by a third-party reviewer and MFDS.KGMP certification must be secured before any medical device company can sell any Class II, III and IV medical devices on the South Korean market. To obtain KGMP certification, medical device companies must submit documentation to MFDS or authorized third party auditor, to demonstrate that their medical devices comply with KGMP quality system requirements. Contact us to learn more about our Medical Device Quality services in South Korea. Our clinical team in South Korea has the expertise in obtaining the CTA approval from MFDS and manage clinical trials for medical device companies efficiently. When medical devices are registered in reference foreign countries, such as US, EU, Canada and Japan, foreign clinical trial data is usually accepted by the MFDS. Local clinical trials are generally not required for device approval, except for certain Class IV medical devices. The MFDS prefers foreign clinical trial data published in a professional journal. However, they will accept unpublished data if the studies were conducted by an acceptable research organization that followed Good Clinical Practice (GCP).There is a total of 166 clinical trial centers designated by MFDS, providing diverse and robust environments for clinical trials. To obtain approval for clinical trials in S. Korea, companies must go through the clinical trial authorization (CTA) process. Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI). Korean PIs must be well educated, trained, and have foreign language abilities. The sponsor and head of the clinical trial site will sign a written contract before the trial begins. If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.In order to conduct the clinical trial itself, companies must execute further steps, including receiving approval from an Institutional Review Board (IRB), recruiting subjects and trial personnel, and ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs in order to determine which documents will be needed. All documents submitted by the sponsor for the clinical trial authorization (CTA) should be in Korean. Contact us to learn more about our Clinical Trial services in South Korea. Consultation meetings with the MFDS can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan. Writing ,Preparation and submission of the meeting package to the health authority,Prepare the questions to health authority based on the status of your product’s development and future plan,Provide support during the meeting,Write the meeting minutes and develop the appropriate action plan after the consultation meeting.GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets. Contact us to learn more about Health Authority Consultation Services for South Korea. South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate. The South Korean regulatory agency, the Ministry of Food and Drug Safety (MFDS), has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product(s) without sufficient knowledge and experience with the S. Korean regulatory authorities can become exhaustive and costly. Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your drug in the South Korea’s market. In South Korea, the holder of a medical product registration must be a S. Korea-based entity. This entity is called the In-Country Caretaker (ICC). Foreign medical companies without their own local Korean office and who do not want to use their distributor as their local agent can have an independent ICC in Korea maintain their product registrations in the name of the foreign manufacturer.An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, documenting and reporting adverse events or product failures, etc.An ICC can also act as a liaison between the foreign manufacturer and its Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests. Contact us to learn more about our Local Agent services in South Korea. Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets. South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate.  Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task. Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign pharmaceutical companies to register their products quickly and efficiently.GRP’s Pharmaceutical Regulatory Strategy Services in South Korea:Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.Proactively identify challenges or issues that may delay the approval of your pharmaceutical in South Korea.Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.Propose innovative solutions and approaches to circumvent these challenges ahead of time.Identify the most cost-effective way to get your pharmaceutical product registered in South Korea. Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in South Korea. Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in South Korea.  GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.GRP’s Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions. Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise MFDS authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules. Consultation meetings with the MFDS can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP regulatory affairs team has organized and supported numerous consultation meeting with the MFDS health authorities. Drug Master File (DMF) preparation: The MFDS requires registration of certain substances, which are subject to DMF registration. A DMF will often contain confidential information on facilities, materials, processes, and packaging. By submitting a DMF to the MFDS, the registered manufacturer can then refer importers or distributors to the registration number without disclosing confidential information to Korean business counterparts.Application submission: Applicants who wish to register their API may submit their application via the Korea Drug Master File (KDMF). Foreign manufacturers of these drug substances or products containing these substances can submit a DMF through a Korean importer or third-party representative with a Korean address. Domestic manufacturers can submit a DMF to the MFDS directly.Once a DMF is submitted, the MFDS will review the documents and conduct a facility inspection. Most applications will need to undergo a facility inspection prior to receiving approval.Once the application is approved, the MFDS will send a letter of acceptance and publicize the names of the DMF sponsors and registered substances. The timeframe is approximately 5-6 months, however, can extend to 8-9 months depending on the current capacity of the MFDS. To obtain approval for clinical trials in S. Korea, companies must go through the clinical trial authorization (CTA) process. Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI). Korean PIs must be well educated, trained, and have foreign language abilities. The sponsor and head of the clinical trial site will sign a written contract before the trial begins. If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.In order to conduct the clinical trial itself, companies must execute further steps, including receiving approval from an Institutional Review Board (IRB), recruiting subjects and trial personnel, and ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs in order to determine which documents will be needed. All documents submitted by the sponsor for the clinical trial authorization (CTA) should be in Korean. Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in South Korea. GRP’s team of professionals can act as your ICC and are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in South Korea. Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in South Korea. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in South Korea. Cosmetics are regulated the Ministry of Food and Drug Safety (MFDS) and the Ministry of Health (MOH).   some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in South Korea’s market. Developing the right regulatory strategy for your products in the South Korean Market is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. To conduct commercial operations in South Korea, under the cosmetic regulation, an enterprise intending to manufacture cosmetics shall be registered as a “manufacturer” while an enterprise that intends to import cosmetics shall be registered as a “Marketing authorization holder”. Foreign manufacturers that want to import cosmetics products into South Korea need to assign an Authorized Local Agent or In- country Caretaker (ICC) who will handle the products’ registration in South Korea. Cosmetics are defined as “Any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human body.” Cosmetics are divided into two categories: Functional Cosmetics and General Cosmetics.  General Cosmetics, are permitted to be manufactured or imported without registration by manufacturers or importers who are registered with the KTFA , and are subject to post-market supervision.Functional Cosmetics, manufacturers and importers are required to undergo an evaluation on safety and efficacy by the MFDS. Approved products require a secondary approval before they can be marketed. In South Korea, Nutraceuticals are known as “Health Functional Food”. They are regulated by the Minister of Food and Drug Safety (MFDS). Health functional foods are products manufactured (and processed) with functional ingredients or elements useful for human health. “Functional” implies adjustment of nutrients in the human body structure or function, or those that bring useful health effects such as in physiological reaction. GRP has a team of experts in South Korea who can help Nutraceutical and food supplements companies in South Korea during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization. Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration. Our nutraceutical regulatory affairs services in South Korea include regulatory intelligence, regulatory strategy, labeling , packaging, nutrient content claims and health claims.  Our Regulatory affairs teams help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the diverse MFDS Regulatory requirements in order to successfully register and commercialize your products in South Korea’s Market. Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the South Korean Regulations.A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement. In addition, MFDS regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared in South Korea.